Valérie Attali1, Marie-Françoise Vecchierini2, Jean-Marc Collet3, Marie-Pia d'Ortho4, Frederic Goutorbe5, Jean-Baptiste Kerbrat6, Damien Leger2, Florent Lavergne7, Christelle Monaca8, Pierre-Jean Monteyrol9, Laurent Morin7, Eric Mullens10, Bernard Pigearias11, Francis Martin12, Fabienne Tordjman12, Hauria Khemliche13, Lionel Lerousseau14, Jean-Claude Meurice15. 1. Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France; AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service des Pathologies du Sommeil (Département "R3S"), Paris, France. Electronic address: valerie.attali@aphp.fr. 2. AP-HP, Hôpital Hôtel Dieu, Centre du Sommeil et de la Vigilance, Paris, France; Université Paris Descartes, Sorbonne Paris Cité, Paris, France. 3. AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Stomatologie et Chirurgie Maxillo-Faciale, Paris, France. 4. AP-HP, DHU FIRE, Hôpital Bichat-Claude Bernard, Physiologie et Explorations Fonctionnelles, Paris, France; UFR de Médecine, Université Denis Diderot Paris 7, Paris, France. 5. Centre Médecine du Sommeil, Centre Hospitalier de Béziers, Béziers, France. 6. AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Stomatologie et Chirurgie Maxillo-Faciale, Paris, France; Hôpital Charles Nicolle, Stomatologie et Chirurgie Maxillo-Faciale, Rouen, France. 7. ResMed Science Center, Saint-Priest, Cedex, France. 8. Hôpital Roger Salengro, Neurophysiologie Clinique, Lille, France. 9. Polyclinique du Tondu, Oto-Rhino-Laryngologie, Bordeaux, France. 10. Fondation Bon Sauveur, Laboratoire du Sommeil, Albi, France. 11. Laboratoire du Sommeil, Nice, France. 12. AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service des Pathologies du Sommeil (Département "R3S"), Paris, France. 13. Groupe Hospitalier Public Sud de l'Oise, Senlis, France. 14. Service de Pneumologie, Centre Hospitalier Antibes, Antibes, France. 15. Centre Hospitalier Universitaire, Pneumologie, Poitiers, France.
Abstract
OBJECTIVE/ BACKGROUND: Mandibular repositioning device (MRD) therapy is an alternative to continuous positive airway pressure (CPAP). The Orkney Complex Disease Study-ORCADES study is assessing the long-term efficacy and tolerability of MRD therapy in obstructive sleep apnoea syndrome (OSAS); two-year follow-up data are presented. PATIENTS/ METHODS: OSAS patients who refused or were noncompliant with CPAP were fitted with a custom-made computer-aided design/computer-aided manufacturing (CAD/CAM) bi-block MRD (ResMed, Narval CC™); mandibular advancement was individually titrated. Sleep and respiratory parameters were determined at baseline, 3-6 months, and two years. The primary endpoint was treatment success (percentage of patients achieving a ≥50% reduction in the apnoea-hypopnoea index [AHI]). RESULTS: Of 315 enrolled patients, 237 remained on MRD treatment at two years, and 197 had follow-up data. The treatment success rate at two years was 67%; AHI <5/h, <10/h and <15/h was achieved in 30%, 56% and 72% of patients, respectively. On multivariate analysis, ≥50% decrease in AHI at 3-6 months and absence of nocturia at 3-6 months were significant predictors of MRD treatment continuation. Adverse events were generally mild, and the majority occurred in the first year of treatment. CONCLUSIONS: Two years' treatment with an MRD was effective and well tolerated in patients with mild to severe OSAS who refused or were intolerant of CPAP.
OBJECTIVE/ BACKGROUND: Mandibular repositioning device (MRD) therapy is an alternative to continuous positive airway pressure (CPAP). The Orkney Complex Disease Study-ORCADES study is assessing the long-term efficacy and tolerability of MRD therapy in obstructive sleep apnoea syndrome (OSAS); two-year follow-up data are presented. PATIENTS/ METHODS:OSASpatients who refused or were noncompliant with CPAP were fitted with a custom-made computer-aided design/computer-aided manufacturing (CAD/CAM) bi-block MRD (ResMed, Narval CC™); mandibular advancement was individually titrated. Sleep and respiratory parameters were determined at baseline, 3-6 months, and two years. The primary endpoint was treatment success (percentage of patients achieving a ≥50% reduction in the apnoea-hypopnoea index [AHI]). RESULTS: Of 315 enrolled patients, 237 remained on MRD treatment at two years, and 197 had follow-up data. The treatment success rate at two years was 67%; AHI <5/h, <10/h and <15/h was achieved in 30%, 56% and 72% of patients, respectively. On multivariate analysis, ≥50% decrease in AHI at 3-6 months and absence of nocturia at 3-6 months were significant predictors of MRD treatment continuation. Adverse events were generally mild, and the majority occurred in the first year of treatment. CONCLUSIONS: Two years' treatment with an MRD was effective and well tolerated in patients with mild to severe OSAS who refused or were intolerant of CPAP.